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Salary: USD 210,000 - 285,000 / annual
Alto Neuroscience is seeking a Senior Director of Regulatory Affairs to lead global regulatory strategy and execution across one or more development programs in precision psychiatry and neuroscience-based therapeutics. This is a senior leadership role that serves as the primary regulatory point of contact (Global Regulatory Leader) with health authorities including FDA, EMA, and MHRA.
Key Responsibilities:
Regulatory Strategy: Develop and lead global regulatory strategy for rare disease and neuroscience programs from IND/CTA through NDA/BLA approval. Serve as GRL for health authority interactions including pre-IND, End-of-Phase 2, and pre-NDA/BLA meetings. Identify, pursue, and manage expedited program designations (Breakthrough Therapy, Fast Track, Special Protocol Assessment, RMAT, Orphan Drug). Author regulatory strategy documents, briefing packages, and health authority meeting materials. Anticipate regulatory risks and advise clinical, executive, and governance leadership on strategy, development options, and risk mitigation.
Submissions & Operations: Oversee planning, content, and quality of regulatory submissions including INDs/CTAs, amendments, annual reports, and meeting requests. Ensure timely, accurate maintenance of submissions and correspondence in Alto's Regulatory Information Management system (KIVO). Coordinate with regulatory publishing partners for eCTD-compliant deliverables. Support inspection readiness and respond to regulatory questions from health authority interactions.
Leadership & Cross-Functional Influence: Provide functional leadership for regulatory strategy across assigned programs, including direction and oversight of regulatory contractors/resources and mentorship of cross-functional team members. Represent regulatory affairs on cross-functional teams and in governance forums. Provide senior regulatory perspective in business development due diligence, portfolio prioritization, and governance discussions. Monitor evolving global regulatory guidance relevant to neuroscience therapeutics and translate implications into program strategy.
The ideal candidate brings deep regulatory strategy experience, a track record of successful expedited-pathway designations, and the ability to operate with sound judgment in a lean, fast-moving biotech environment. Occasional travel required for health authority meetings, investigator/site engagement, and team offsites.
Requirements:
Required:
- Advanced degree in a scientific, medical, or health-related discipline (PhD, PharmD, MD, or MS with extensive experience)
- 15+ years of progressive regulatory affairs experience in biotech or pharma, including significant experience leading global regulatory strategy and serving as regulatory lead for development programs
- Demonstrated success leading health authority interactions and securing expedited designations (Breakthrough Therapy, Fast Track, SPA)
- Direct experience as regulatory lead on IND/CTA through NDA/BLA/MAA program; multiple NDA approvals preferred
- Strong working knowledge of ICH guidelines, GCP, and global regulatory requirements
- Excellent strategic, written, and verbal communication skills with ability to influence senior stakeholders
- Ability to operate independently and manage ambiguity in a fast-paced, resource-lean biotech environment
- Responsible for managing vendors supporting regulatory activities with potential for 1-2 direct reports
Bonus Skills:
- Neuroscience therapeutic area expertise directly relevant to Alto's pipeline; experience with other therapeutic areas and rare disease a plus
- Experience with Regulatory Information Management systems (Veeva, KIVO) and eCTD publishing workflows
- Demonstrated ability to build, scale, or strengthen regulatory strategy capabilities in growth-stage or resource-lean biotech
- Experience working with FDA CSS and FDA Advisory Committees
- Experience supporting business development due diligence from regulatory perspective
